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For years, the FDA has had a somewhat laissez-faire attitude towards dietary supplements. Now, for the first time in more than 25 years, they’re shaking up their act. That’s according to commissioner Scott Gottlieb, who announced on Monday that the agency is overhauling their approach to how supplements are regulated. Here’s what you need to know about the FDA Food Supplement Overhaul.
To prove that they’re serious, the agency sent out 17 warning letters on February 11 to the makers of various supplements that purportedly can treat, prevent, or cure Alzheimer’s disease. The agency is claiming that the companies they warned are illegally selling the products, which have not been evaluated for their effectiveness against Alzheimer’s, and they’re asking them to stop.
The FDA is in a bit of a strange position. Under current law, you can claim that your dietary supplement has health benefits, but you can’t claim that it can be used to treat a particular disease. The FDA has tools for dealing with drugs that masquerade as supplements, or with supplements that are spiked with dangerous ingredients. Those tools, however, are largely reactive; they can issue a warning letter asking the company to stop marketing their products in that way, or to stop selling them, and they can bring legal action against the company if they don’t comply.
This is because dietary supplements aren’t regulated in the same ways that medicines are. If you want to come up with a new drug that treats Alzheimer’s, you have to put it through all kinds of tests to prove that it’s safe. The approval process is long and arduous. Trials in animals need to be done before the drug can even be tested on human subjects. There’s multiple reviews and public comment periods. All of this needs to be done before you can legally market and sell the drug.
That’s only true if you’re trying to sell the drug as medicine, however. If you’d like to be sneaky, you can try selling it as a dietary supplement, you don’t need to demonstrate to the government that it’s safe before you bring it to market. This is, as we said above, against the rules, but that hasn’t stopped companies from trying it.
When you buy a supplement, then, you don’t know whether or not it’s actually going to do what it says on the tin. You don’t know whether it includes an active ingredient that’s going to change what your body is doing. And you don’t know whether it also includes other things, some of which might actually be actively harmful to you.
The supplement industry, loosed from the restrictions that govern manufacturers of food and drugs, has grown to titanic proportions. Supplements are now an $40 billion dollar market in the United States. Many of them are sold online, where overhead for setting up a storefront is low; just set up a webpage, buy some ad space on Facebook or Google, and start shipping your product to people’s houses.
The FDA is trying to improve the tools that they have to react to people selling shady supplements in this large and largely unregulated market. They’re creating and debuting a new rapid response tool that allows people to more easily report supplement manufacturers who they suspect aren’t strictly following the rules.
They’re changing how a few other things work as well. Right now, supplement manufacturers have to report if they’re using a New Dietary Ingredient, or NDI – that is to say, one that wasn’t around before 1994. The agency is updating their compliance policies so that they can keep a closer eye on these new ingredients.
Says commissioner Scott Gottlieb: “An effective NDI notification process represents the FDA’s only opportunity to evaluate the safety of a new ingredient before it becomes available to consumers and helps promote transparency and risk-based allocation of resources.”
Not all of the potentially harmful things in supplements are newly synthesized, extracted, or otherwise derived in a lab. Some come straight from plants. That’s the case with kava, for example. It’s the national drink of Fiji and has natural relaxant properties; some people have called it “nature’s Xanax.” It also may or may not be harmful to the liver.
To better manage plant ingredients in supplements, the FDA is setting up a botanical safety consortium. They say that it’s a “public-private partnership that will gather leading scientific minds from industry, academia and government to promote scientific advances in evaluating the safety of botanical ingredients and mixtures in dietary supplements. This group will look at novel ways to use cutting-edge toxicology tools, including alternatives to animal testing, to promote the goals of safety and effectiveness we share with consumers and other stakeholders.”
Finally, they’ll be looking into whether or not an updated regulatory framework for supplements is needed. It’s been more than a quarter-century since the relevant legislation was passed, after all, and right now we don’t have many ways of telling whether or not dietary supplements actually do what they say. The relatively loose environment around supplements has created a huge market for them, but how are consumers supposed to make informed decisions in that market without a stronger review process from the FDA?
That’s a question we ask a lot here at Make Food Safe. Because we’re in the business of trying to make food safer, however, we’re usually on the side of calling for more restrictions. Reasonable people disagree about whether that’s a good idea or whether it would choke the market and put a lot of innocent and law-abiding supplement hawkers out of business. Let us know what you think and watch this space for more updates on actions that the FDA or lawmakers take in the future.
By: Sean McNulty, Contributing Writer (Non-Lawyer)